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Pilot Study for Cell Based Therapies in Patients With Asthma

Primary Purpose

Asthma, Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood donation
Sponsored by
Fraunhofer-Institute of Toxicology and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male subjects suffering from allergic rhinitis and/or allergic asthma against timothy grass pollen (phleum pratense) and/or house dust mite.
  • age 18-60 years,
  • Nonsmokers or smokers with a history of less than 1 pack years who have not smoked within the last 12 months.
  • Positive skin prick test for timothy grass pollen (phleum pratense) and/or house dust mile within 12 months
  • Able and willing to give written informed consent
  • Hemoglobin ≥135 g/l
  • Hematocrit ≥ 0,40
  • Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19-32 kg/m²

Exclusion Criteria:

  • History of lower respiratory tract infection and /or exacerbation of asthma within four weeks prior to the informed consent visit
  • Febrile illness within four week before the trial examination
  • Administration of oral, injectable, or dermal corticosteroids within the last 8 weeks or intranasal and/or inhaled corticosteroids within the last 4 weeks.
  • Intake of methylxanthines, antihistamines, antileukotrienes, oral cromolyn sodium, or oral nedocromil sodium
  • Past or present disease, which as judged by the investigator, may affect the outcome of this trial. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
  • Specific immunotherapy (SIT) within the last two years prior to screening
  • Participation in another clinical trial 30 days prior to enrollment
  • Donation of more than 500 ml of blood in the preceding 9 weeks before the trial-examination
  • Hemoglobin below the normal lower limit
  • History of drug and/or alcohol abuse or dependence within 12 months of the trial
  • Risk of non-compliance with trial procedures
  • Suspected inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
  • Patient is tested human immunodeficiency virus (HIV)-1/2Ab, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab) positive

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Blood donation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2010
    Last Updated
    November 8, 2011
    Sponsor
    Fraunhofer-Institute of Toxicology and Experimental Medicine
    Collaborators
    Hannover Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01087515
    Brief Title
    Pilot Study for Cell Based Therapies in Patients With Asthma
    Official Title
    Development and Validation of Magnetic Cell Separations Techniques Using a Good Manufacturing Practice (GMP) Grade Manufacturing Process for Clinical Applications and Generation of Pre-clinical Data
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fraunhofer-Institute of Toxicology and Experimental Medicine
    Collaborators
    Hannover Medical School

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to investigate the immunomodulatory potential of Isolated Plasmacytoide Dendritic Cells (pDCs) and Regulatory T-cells (TREGs) isolated with clinical grade magnetic bead isolations techniques (MACS®) on the antigen presenting cell-induced proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.
    Detailed Description
    pDCs as well as TREGs will be co-incubated with generated allergen presenting cells, lymphocytes, and allergen. For in vitro experimentation immune cells will be collected from blood of grass mix or house dust mite sensitized atopic/asthmatic patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blood donation
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Blood donation
    Intervention Description
    In experimental part 1 to generate preclinical data 250 ml of blood will be donated at day 1 by 10 subjects to induce allergen presenting cells (APCs). In experimental part 2 to transfer the isolation of pDC or TREGs to a GMP (good manufacturing Practice) compliant clinical grade isolation system, leukapheresis will be performed with the blood from 5 subjects. In experimental part 3 for potency testing of the clinical grade isolation system of pDC or TREGs, 250 ml of blood will be collected at day 1 from 3 subjects.
    Primary Outcome Measure Information:
    Title
    Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male subjects suffering from allergic rhinitis and/or allergic asthma against timothy grass pollen (phleum pratense) and/or house dust mite. age 18-60 years, Nonsmokers or smokers with a history of less than 1 pack years who have not smoked within the last 12 months. Positive skin prick test for timothy grass pollen (phleum pratense) and/or house dust mile within 12 months Able and willing to give written informed consent Hemoglobin ≥135 g/l Hematocrit ≥ 0,40 Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19-32 kg/m² Exclusion Criteria: History of lower respiratory tract infection and /or exacerbation of asthma within four weeks prior to the informed consent visit Febrile illness within four week before the trial examination Administration of oral, injectable, or dermal corticosteroids within the last 8 weeks or intranasal and/or inhaled corticosteroids within the last 4 weeks. Intake of methylxanthines, antihistamines, antileukotrienes, oral cromolyn sodium, or oral nedocromil sodium Past or present disease, which as judged by the investigator, may affect the outcome of this trial. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis). Specific immunotherapy (SIT) within the last two years prior to screening Participation in another clinical trial 30 days prior to enrollment Donation of more than 500 ml of blood in the preceding 9 weeks before the trial-examination Hemoglobin below the normal lower limit History of drug and/or alcohol abuse or dependence within 12 months of the trial Risk of non-compliance with trial procedures Suspected inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial Patient is tested human immunodeficiency virus (HIV)-1/2Ab, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab) positive
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Norbert Krug, MD
    Organizational Affiliation
    Fraunhofer Institute for Toxicology and Experimental Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Study for Cell Based Therapies in Patients With Asthma

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